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Understanding Process Validation in Biotechnology Manufactur
Understanding Process Validation in Biotechnology Manufactur
Understanding Process Validation in Biotechnology Manufacturing
US FDA’s Draft 2008 Process Validation Guidelines provide and excellent framework for understanding Process Validation. They describe the principles and approaches that FDA feels the industry should use in executing validation life cycle activities for developing and producing biopharmaceuticals. This fundamental On-line Learning course introduces and uses some new terms and concepts not found in the US FDA 2008 draft guidelines. Those planning to use the guidelines should read and understand them, including the final version when it is approved, for specific guidance. At the conclusion of this course, participants will be able to:

  • Understand how to manage the uncertainties inherent in biotechnology manufacturing.
  • Define and explain the framework for structuring the process validation effort.
  • Describe and identify tools used to support process validation.

Speaker Biography

Mark Witcher, Ph.D is a Senior Consultant for IPS - Integrated Project Services in Morrisville, NC. At IPS, Mark does feasibility and concept process designs and operational plan development for novel and advanced facility designs. Prior to joining IPS in 2011, he was a consultant in the biopharmaceutical industry for 15 years on operational issues related to: Process development, product development; strategic business development; clinical and commercial manufacturing planning; tech transfer; and facility design and construction. He teaches courses on process validation for ISPE. He was previously the Sr. Vice President, Manufacturing Operations for Covance Biotechnology Services (formerly Corning Bio, Inc.). At Covance, he was responsible for the design, construction, start-up, and operation of Covance's $50MM contract manufacturing facility. Prior to joining Covance in 1995, he was Vice President of Manufacturing for Amgen, Inc. Mark was with Amgen for nine years and also held positions as Engineering Manager, Plant Manager, and Director of EPOGEN® Manufacturing. Mark received his Ph.D. in Chemical Engineering from the University of Massachusetts.
Discounted member price: 99.00
You could save 33.6%
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation when required.

Approximate Course Duration: 45 minutes (this is a self-paced course)

*NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

Member Price: $ 99.00 / € 81.00
Non Member Price: $ 149.00 / € 122.00